Investigation of the effect of using manual U-shaped toothbrushes compared to regular toothbrushes on the removal of children's dental plaque.
Design
Cross-over clinical trial, on 30 people, all of them are in the intervention and control groups, double-blinded, randomization for the order of using toothbrushes by randomized.org
Settings and conduct
30 children who meet the conditions of entry and non-entry are selected and the order of toothbrushes (regular toothbrush and manual U-shaped toothbrush) is determined for each person. 5 follow-ups are considered for each child. (zero, two weeks, four weeks/zero, two weeks, four weeks) In the first session (zero), after measuring the plaque index, complete prophylaxis is performed and the first toothbrush is delivered to the child. At the end of the first month (the third session), after the plaque index is recorded, prophylaxis is performed and the second toothbrush is delivered, and after that, two more examinations are performed with an interval of 2 weeks between each follow-up.
Examinations related to the study are performed in the children's department of Mashhad Dental faculty.
The toothbrush provider/examiner/index recorder as well as the data analyzer is blinded to the toothbrush used by each child.
Participants/Inclusion and exclusion criteria
entry conditions:
4 to 7 years old child
Having at least 20 teeth in the mouth
prohibition conditions:
Being without a parent/absence or the lack of interest of parent and child
A specific physical or mental problem that prevents the child from brushing the teeth
Intervention groups
The study is cross-over.
Intervention group: manual u-shaped toothbrush
Control group: conventional child's toothbrush
Main outcome variables
Quigley-Hein plaque index and BOP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240601061977N1
Registration date:2024-07-12, 1403/04/22
Registration timing:registered_while_recruiting
Last update:2024-07-12, 1403/04/22
Update count:0
Registration date
2024-07-12, 1403/04/22
Registrant information
Name
Hamed Hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 7701
Email address
hamed.8a6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation of the effect of using a manual U-shaped toothbrush in dental plaque removal of 4 to 7 years old children: A pilot study
Public title
effect of using a manual U-shaped toothbrush in dental plaque removal
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
4 to 7 years old child
Having sufficient physical and mental ability of the child and parent
Having at least 20 teeth in the mouth
Not having an appliance like an astronaut
Having physical health and the absence of diseases that cause gingivitis
Exclusion criteria:
Being without a parent/absence or the lack of interest of parent and child
A specific physical or mental problem that prevents the child from brushing the teeth
Possible allergy to silicone materials
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The study is cross-over and all children receive both a conventional toothbrush and a U-shaped toothbrush. Randomization for the order of each person's use of two types of toothbrushes is done by randomized.org and a random sequence is created for each person. For example, if a sequence of a, b is made for a person, the child should use toothbrush a in the first month and toothbrush b in the second month.
Blinding (investigator's opinion)
Double blinded
Blinding description
Toothbrushes are presented in opaque containers. The person presenting and examining and recording the indicators does not know about the toothbrush used by the child. The data analyst is also blind.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad dentistry faculty
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1403.054
Health conditions studied
1
Description of health condition studied
Dental caries, gingivitis, dental plaque
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Quigley-Hein dental plaque index: based on the amount of plaque, one of 6 points is considered: score 0: the surface is free of plaque, score 1: plaque is scattered in the cervical part of the tooth, score 2: plaque in the form of a thin continuous line with thickness A maximum of one millimeter in the cervical region of the tooth. Score 3: The plaque thickness is greater than one millimeter but covers less than one third of the tooth crown. Score 4: The plaque thickness covers more than one third but less than two thirds of the tooth crown. Score 5: Plaque covers two thirds or more of the tooth crown BOP (bleeding on probing) index: A few seconds after examining each tooth, bleeding from the sulcus is checked and recorded as positive or negative for each tooth.
Timepoint
At the beginning of the study (the day the first toothbrush was delivered), 2 weeks, 4 weeks, 6 weeks and 8 weeks after the first session (0, 2, 4, 6, 8 weeks)
Method of measurement
The plaque index variable as well as bop (bleeding on probing) is measured by the World Health Organization (WHO) probe. In this way, the probe is placed in the gingival sulcus of each surface and is moved from mesial to distal, and scores are given based on the surface and height of the plaque collected on the probe and the tooth. A few seconds after moving the probe, the bop is also checked.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The clinical trial is a cross-over type and all the statistical population (30 people) are included in the intervention group and the control group. Intervention is a manual U-shaped toothbrush. In this way, all 30 people use a U-shaped toothbrush for a period of one month. It is explained to parents and children that the toothbrush should be used with the toothpaste provided (Pouneh toothpaste) three times a day. How to use a toothbrush is also sent to parents verbally and through an educational video.
Category
Prevention
2
Description
Control group: The clinical trial is a cross-over type and all the statistical population (30 people) are included in the intervention group and the control group. The control group receives a conventional child's toothbrush. In this way, all 30 people use a conventional toothbrush for a period of one month. It is explained to parents and children that the toothbrush should be used with the toothpaste provided (Pouneh toothpaste) three times a day. How to use a toothbrush is also sent to parents verbally and through an educational video.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Department of Mashhad Dentistry Faculty
Full name of responsible person
Ali Basiri
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3806 7100
Email
hamed.8a6@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Moghaddas
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3806 7100
Email
hamed.8a6@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Hamidi
Position
Undergraduate Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 5725 7701
Email
hamed.8a6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Hamidi
Position
Undergraduate Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 5725 7701
Email
hamed.8a6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Hamidi
Position
Undergraduate Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, in front of Mellat Parkat, at the beginning of Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 5725 7701
Email
hamed.8a6@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available